PLS GMP Data Reviewer (Pharma)

Shift:

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

This is a full-time, onsite, GMP Data Reviewer position located in Oakdale, MN,Monday through Friday, 8:30 a.m. - 5:00 p.m.

Compensation: $55,000 - $65,000 per year

The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate's geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer.

Make an Impact. Build a Career.

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization.

Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

SUMMARY

Responsible for providing advanced oversight of the analysis and administration of various quality policies, programs, and practices in accordance with current Good Manufacturing Practices (cGMP); provides feedback, direction and guidance to employees and management, using advanced professional and technical knowledge of quality or related equipment, testing, and procedures.

ESSENTIAL FUNCTIONS

This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and

skills.

• Overseeing, reviewing, writing, updating, completing, and processing quality forms, documents, databases, and related materials and information. This includes, but is not limited to manufacturing batch records, technical records, pertinent laboratory or quality control data, standard operating procedures (SOPs), quality exceptions, logbooks, tracking systems and LIMS data/reports. Data and records may be in the form of electronic or paper records or laboratory notebooks.

• Provides intermediate to complex analysis, interpretation and counsel to staff, management, and functional leaders regarding quality policies, programs, and practices; involves varied operations and leading implementation and change.

• Provides various research, feedback, and decisions to resolve management and employee questions and requirements; assists with receiving customer feedback and coordinating resources and responses as required.

• Analyzes and reviews intermediate to complex operations, results, feedback, and related quality information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management.

• Ensures the accuracy of various tests, equipment, actions, procedures and operational databases, reports, and related details through audits, queries, and operational reviews; works with teams to resolve discrepancies.

• Assists with developing or participating in quality or cross-functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management.

• Interprets and applies department policies and procedures and assists with applicable laws, rules, and regulations; receives guidance within these areas as needed.

• Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.

• Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and Experience

Bachelor's degree in chemistry, operations, or a closely related field; AND two to four (2-4) years of quality experience, including experience with complex programs or operations; OR an equivalent combination of education, training, and experience.

Required Knowledge and Skills

Required Knowledge

• Intermediate to complex principles, practices, and techniques of quality.

• Various understanding of the administration and oversight of quality programs, policies, and procedures.

• Intermediate to complex methods to resolve quality problems, questions, and concerns.

• Various understanding of applicable quality laws, codes, and regulations.

• Understanding of various testing tools, equipment, and calibration.

• Computer applications and systems related to the work.

• Principles and practices to serving as an effective project team member.

• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.

• Correct business English, including spelling, grammar, and punctuation.

Required Skills

• Performing intermediate to complex professional-level quality duties in a variety of assigned areas.

• Overseeing and administering comprehensive and varied quality functions.

• Training others in policies and procedures related to the work.

• Serving as a team member and the development and management of projects.

• Operating in a both a team and individual contributor environment.

• Interpreting, applying, and explaining applicable laws, codes, and regulations.

• Preparing intermediate to complex functionals reports, correspondence, and other written materials.

• Using initiative and independent judgment within established department guidelines.

• Using tact, discretion, and prudence in working with those contacted in the course of the work.

• Performing effective oral presentations to large and small groups across functional peers and the department.

• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.

• Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

PHYSICAL/MENTAL REQUIREMENTS

The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

WORKING ENVIRONMENT

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gases, noxious odors and related items in a lab setting.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.